FDA approves a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSci...
A 50-member organization of environmental, public health and childrens rights groups calls on FDA to act in line with the rest of the federal governme...
Sen. Charles Grassley asks HHS and FDA for information on a Florida stem cell clinic that conducted an unapproved clinical trial in which three patien...
FDA medical reviewers say they see a positive risk-benefit profile in GW Pharmas cannabdiol for treating two specific seiure syndromes in patients ove...
Federal Register notice: FDA makes available a guidance entitled Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic D...
Federal Register notice: FDA makes available a draft guidance entitled Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission...
Federal Register notice: FDA makes available a guidance entitled Special Protocol Assessment (SPA) that provides information about the procedures and ...
FDA commissioner Scott Gottlieb announces a sweeping reorganization of CDRH, saying it is introducing a Medical Device Safety Action Plan focusing on ...